Neuro Plating System
Model NBS304S05A · OSTEONIC CO.,Ltd. · DI 08809416061856
GWO — Plate, Cranioplasty, Preformed, Alterable · Class II · 21 CFR 882.5320
GXR — Cover, Burr Hole · Class II · 21 CFR 882.5250
HBW — Fastener, Plate, Cranioplasty · Class II · 21 CFR 882.5360
UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.5 |
| 2019-02 | 0 | 1 |
| 2019-03 | 0 | 2.71 |
| 2019-04 | 0 | 1.55 |
| 2019-05 | 0 | 2.4 |
| 2019-06 | 0 | 1.4 |
| 2019-07 | 0 | 1.67 |
| 2019-08 | 0 | 2.17 |
| 2019-09 | 0 | 1.7 |
| 2019-10 | 0 | 2 |
| 2019-11 | 0 | 2.5 |
| 2019-12 | 0 | 9.5 |
| 2020-01 | 0 | 2.37 |
| 2020-02 | 0 | 1.72 |
| 2020-03 | 0 | 3 |
| 2020-04 | 0 | 1.86 |
| 2020-05 | 0 | 2.43 |
| 2020-06 | 0 | 2.7 |
| 2020-07 | 0 | 2.88 |
| 2020-08 | 0 | 1.9 |
| 2020-09 | 0 | 3.5 |
| 2020-10 | 0 | 2.12 |
| 2020-11 | 0 | 2.13 |
| 2020-12 | 0 | 2.71 |
| 2021-01 | 0 | 1.75 |
| 2021-02 | 0 | 1.75 |
| 2021-03 | 0 | 2.56 |
| 2021-04 | 0 | 4.8 |
| 2021-05 | 0 | 1.82 |
| 2021-06 | 0 | 2.09 |
| 2021-07 | 0 | 1.19 |
| 2021-08 | 0 | 2.59 |
| 2021-09 | 0 | 1.89 |
| 2021-10 | 0 | 2.39 |
| 2021-11 | 0 | 1.55 |
| 2021-12 | 0 | 1.85 |
| 2022-01 | 0 | 2.54 |
| 2022-02 | 0 | 5.36 |
| 2022-03 | 0 | 4.44 |
| 2022-04 | 0 | 1.08 |
| 2022-05 | 0 | 1.53 |
| 2022-06 | 0 | 5 |
| 2022-07 | 0 | 1.75 |
| 2022-08 | 0 | 1.8 |
| 2022-09 | 0 | 1.43 |
| 2022-10 | 0 | 1.5 |
| 2022-11 | 0 | 2.43 |
| 2022-12 | 0 | 3.93 |
| 2023-01 | 0 | 2.17 |
| 2023-02 | 0 | 2 |
| 2023-03 | 0 | 4.38 |
| 2023-04 | 0 | 9.5 |
| 2023-05 | 0 | 1.33 |
| 2023-06 | 0 | 8.11 |
| 2023-07 | 0 | 1.76 |
| 2023-08 | 0 | 1.63 |
| 2023-09 | 0 | 2.22 |
| 2023-10 | 0 | 2.7 |
| 2023-11 | 0 | 2.5 |
| 2023-12 | 0 | 1.43 |
| 2024-01 | 0 | 4.5 |
| 2024-02 | 0 | 2.7 |
| 2024-03 | 0 | 2.5 |
| 2024-04 | 0 | 2.96 |
| 2024-05 | 0 | 1.67 |
| 2024-06 | 0 | 1.7 |
| 2024-07 | 0 | 1 |
| 2024-08 | 0 | 1.29 |
| 2024-09 | 0 | 4.67 |
| 2024-10 | 0 | 4.73 |
| 2024-11 | 0 | 3.5 |
| 2024-12 | 0 | 1.43 |
| 2025-01 | 0 | 1.7 |
| 2025-02 | 0 | 1 |
| 2025-03 | 0 | 1.83 |
| 2025-04 | 0 | 1.86 |
| 2025-05 | 0 | 2.88 |
| 2025-06 | 0 | 2.29 |
| 2025-07 | 0 | 4.1 |
| 2025-08 | 0 | 1.5 |
| 2025-09 | 0 | 1 |
| 2025-10 | 0 | 1.36 |
| 2025-11 | 0 | 1 |
| 2025-12 | 0 | 3.86 |
| 2026-01 | 0 | 2 |
| 2026-02 | 0 | 1.8 |
| 2026-03 | 0 | 3.33 |
| 2026-04 | 0 | 8.86 |
| 2026-05 | 0 | 2.79 |
| 2026-06 | 0 | 4.57 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K141911 — cites (transitively): K100205 (d1), K112812 (d1), K121624 (d1), K091679 (d2), K103778 (d2), K854886 (d2), K922741 (d2), K953385 (d2) — cited as predicate by K183352, K190811, K212391
K190811 — cites (transitively): K141911 (d1), K183352 (d1), K100205 (d2), K112812 (d2), K121624 (d2), K091679 (d3), K103778 (d3), K854886 (d3), K922741 (d3), K953385 (d3) — cited as predicate by K210360
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — OSTEONIC CO.,Ltd.
Nothing in the loaded window.